RESEARCH - Safety, response, and pharmacokinetics of an experimental Remicade formulation for SC and IM administration in RA

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J Rheumatol. 2006 Apr 1; [Epub ahead of print]

A Phase I Study Assessing the Safety, Clinical Response, and

Pharmacokinetics of an Experimental Infliximab Formulation for Subcutaneous

or Intramuscular Administration in Patients with Rheumatoid Arthritis.

Westhovens R, Houssiau F, Joly J, Everitt DE, Bouman-Thio E, Zhu Y, Sisco D,

Van Hartingsveldt B, Mascelli MA, Graham MA, Durez P.

OBJECTIVE: To assess safety, clinical response, and pharmacokinetics of

subcutaneous (SC) and intramuscular (IM) doses of an experimental

formulation of infliximab [including experimental SC doses following

administration of commercially-formulated intravenous (IV) infliximab] in

patients with rheumatoid arthritis (RA) refractory to methotrexate. METHODS:

In this randomized, open-label, 3-stage design, 43 subjects were enrolled in

7 dose groups. In Stage I, 15 subjects received single SC doses of 0.5, 1.5,

or 3.0 mg/kg. In Stage II, 21 subjects received one of 3 regimens: 100 mg SC

every 2 weeks (3 injections); 3 mg/kg commercially-formulated IV infliximab

every 2 weeks (2 infusions) followed by 100 mg SC every 2 weeks (3

injections); or 100 mg IM every 2 weeks (3 injections). In Stage III, 7

subjects received 100 mg SC every 4 weeks (3 injections). RESULTS: No

treatment-related serious adverse events were observed, and there were no

serious injection site reactions. A low-titer infliximab antibody response

was detected in 27% of subjects receiving single SC doses, 5% receiving

multiple SC doses, and 43% receiving IM doses. SC administration yielded

roughly dose-proportional increases in Cmax and AUC. American College of

Rheumatology 20% response (ACR20) was achieved 2 weeks after the last

injection by 86.7% of subjects receiving single SC doses, 85.7% receiving SC

doses every 2 weeks, 85.7% receiving both IV and SC doses, 57.1% receiving

multiple IM doses, and 80.0% receiving SC doses every 4 weeks.

CONCLUSION: SC and IM treatment with this experimental infliximab

formulation was well tolerated and was associated with a favorable ACR

response.

PMID: 16583466

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=1\

6583466

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